The test detect signs of colorectal cancer and precancerous growths using a home collection kit.
Labcorp announced the nationwide availability of ColoSense, an RNA-based at-home screening test for colorectal cancer approved by the Food and Drug Administration (FDA).
Offered through a commercial collaboration with test developer Geneoscopy, the test expands Labcorp’s range of colorectal cancer screening solutions. The test is now covered for eligible Medicare and Medicare Advantage beneficiaries following an update to the National Coverage Determination by the Centers for Medicare & Medicaid Services in June, with additional commercial coverage also available.
ColoSense uses RNA-based technology to detect biomarkers associated with colorectal cancer and advanced adenomas, which are precancerous changes that may be an early indication of disease. The test aligns with stool-based RNA screening approaches recognized in the American Cancer Society colorectal cancer screening guidelines and is included as a recommended screening option in the National Comprehensive Cancer Network guidelines.
“Labcorp is focused on improving colorectal cancer screening rates by offering at-home options consumers are more likely to complete,” says Brian Caveney, chief medical and scientific officer at Labcorp, in a release. “With ColoSense now available nationwide, we’re expanding access to an FDA-approved screening option that delivers advanced science and a more streamlined, easier-to-use collection experience.”
The test is available through healthcare providers for adults aged 45 to 85 at average risk. It is not intended for individuals with a history of colorectal cancer or certain high-risk conditions. In clinical performance evaluations, the test demonstrated 93% sensitivity for colorectal cancer in average-risk individuals and achieved 100% sensitivity for stage I colorectal cancer, according to the company.
“ColoSense reflects years of scientific innovation focused on improving how we screen for colorectal cancer at home,” says Matt Sargent, chief commercial officer at Geneoscopy, in a release.
The collection kit is delivered directly to the consumer’s home and features a design that eliminates the need to separate or mix the stool sample. Labcorp research indicates that among users of at-home screening tests, 41% were uncomfortable preparing the sample, and 34% said the process felt messy.
Geneoscopy provides patient navigation support to help individuals understand their results and follow recommended next steps, including a colonoscopy after a positive result. Labcorp notes that ColoSense is a screening test and does not replace diagnostic colonoscopy.
Photo caption: ColoSense Kit
Photo provided: Labcorp
